Colombia Wins International Litigation to Produce Generics of a Drug Used to Treat HIV

Colombia obtained a favorable ruling in the international dispute initiated by the pharmaceutical companies ViiV Healthcare Company (United Kingdom) and Shionogi & Co., Ltd. (Japan), related to the compulsory license of dolutegravir, a key medication in the treatment of HIV. The litigation was being carried out before the Court of Justice of the Andean Community, based in Quito, which ruled in favor of Colombia.

The decision represents a victory for the country by maintaining the measure that allows a significant reduction in the cost of the drug. While the British and Japanese companies sought to limit access to the medication and keep prices above 200 dollars, the compulsory license allows dolutegravir to be marketed at around 6 dollars, facilitating treatment for patients with limited resources or who depend on the public health system.

The Court of Justice of the Andean Community confirmed the validity of the compulsory license granted in Colombia, supporting the actions of national authorities and closing the litigation that had put under review the resolutions issued regarding this treatment. ViiV Healthcare Company and Shionogi & Co. argued that the compulsory license imposed by the Ministry of Health in 2024, in an unprecedented decision that authorized the manufacture and import of the drug for reasons of public interest, was illegal.

Court states that Colombia did not incur in breaches

The Ministry of Health highlighted that the ruling sets a precedent in the region, by endorsing the use of this type of tools to guarantee access to essential medicines. The pharmaceutical companies holding the patent had questioned the legality of the decisions adopted by the country, which gave rise to the international dispute.

The case dates back to October 2023, when the Ministry of Health issued Resolution 1579, through which it declared reasons of public interest to move forward with the compulsory license on a patent related to dolutegravir.

Thus, the Government authorized other manufacturers to produce or import generic versions of dolutegravir without permission from the patent owner. It sought to reduce prices and expand access to that medication. Immediately, the pharmaceutical companies sued the Colombian State arguing that this measure violated their intellectual property rights.

The measure was based on the need to strengthen the health system’s response to HIV and AIDS. After reviewing the decisions adopted between 2023 and 2024, the court concluded that Colombia did not incur in breaches of Andean regulations, leaving the compulsory license in force.

With this ruling, the dispute is closed at the regional level and the legality of the measures adopted by the country is ratified, in what is considered a key precedent for access to medicines and the protection of public health.

As a consequence of the government measure, the reduction in prices has been evident: According to the National Commission on Drug Prices, a bottle of 30 tablets of 50 mg cost around 480,000 pesos (US$95 at the exchange rate at the time) in 2023, before the compulsory license. With generic versions the cost has dropped to about 15,000 pesos (US$4) per bottle, a reduction of more than 90% and it allows expanding coverage.